NCT05526729

Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 222 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.

Detailed description

This study aimed to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients. The observation period was 1 year (52 weeks) from the first Beovu administration in the primary treated eye. In patients discontinuing treatment with Beovu in the primary treated eye before Week 52, the following observation periods applied. * Date of last Beovu dose + 90 days\* in primary treated eye \> Week 52: up to Week 52 * Date of last Beovu dose + 90 days\* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days \*90 days: to collect as much data as possible considering clinical effects

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
OTHER	Beovu	Prospective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study.

Timeline

• Start date: 2022-09-02
• Primary completion: 2024-06-29
• Completion: 2024-06-29
• First posted: 2022-09-02
• Last updated: 2025-06-13

Locations

76 sites across 1 country: Japan